Amgen Patent Ploy Undercuts Healthcare Law
There is an old saying about what a difference a day makes. Well, what about 17 years? For Amgen, or any drugmaker that wins a new patent on an existing med, that can, of course, mean untold amounts of money. And this appears to be in the offing for the biotech, which was just awarded […]
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Merck KGgA To Facebook: Where Is Our Page?
Call this the case of the missing Facebook page. Merck KGgA, the drugmaker based in Germany, has filed a lawsuit in hopes of forcing Facebook to explain how its page on the wildly popular social network was apparently misappropriated by that other Merck – the drugmaker based in the US. Somehow, you see, its Facebook […]
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Thalidomide is still casting dark shadows 50 years on
This year marks the 50th anniversary of the withdrawal of thalidomide from the market. Launched as a drug for treating morning sickness, it unexpectedly gave rise to severe abnormalities, including the absence of limbs in several thousand children around the world. The episode was, undoubtedly, a profound tragedy. Yet its lasting consequence has been to […]
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Like Candy? Foster Kids Get More Antipsychotics
In the latest reason for concern about prescribing antipsychotics for children, a study finds that foster kids are being prescribed combinations of antipsychotics just as frequently as some of the most mentally disabled youngsters on Medicaid. And the findings underscore a growing trend to prescribe these meds, which are approved only for schizophrenia and bipolard […]
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Those Returns On R&D Are Falling Fast
It is no secret that every big drugmaker is struggling to transform research and development in the wake of the infamous patent cliff and accompany pipeline problems. But how have they been faring? A new report suggests what investors have largely known – not so well. Of a dozen big drugmakers analyzed, 10 showed a […]
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Gilead Is Paying How Much For Pharmasset?
For those keeping close watch on the Hepatitis C market or biotech stocks this morning, the $11 billion deal in which Gilead Sciences agreed to buy Pharmasset is now well known. But does it make sense? And if so, for which side of the table? Gilead shares, for instance, are down nearly 5 percent, although […]
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Former Synthes Execs Jailed For Fatal Clinical Trial
Three executives from Synthes, a device maker that was recently purchased by Johnson & Johnson, were sentenced yesterday to prison for their roles in an unapproved trial of a bone-cement drug that led to three patient deaths. A fourth exec will be sentenced later. All four pleaded guilty to one misdemeanor count of shipping an […]
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Bayer Keeps Confidential Documents Under Wraps
A federal judge has denied an effort by a plaintiff in the sprawling litigation involving the Yaz and Yasmin contraceptive pills to provide confidential documents to the FDA in advance of a December 8 advisory committee meeting. The panel will examine the risk of blood clots caused by birth control pills containing drospirenone, and the […]
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FDA Yanks Breast Cancer Indication For Avastin
After more than a year of controversy and anticipation, the FDA has decided to formally yank the breast cancer indication for Avastin after deciding the widely used medication is not safe and effective for that purpose. However, the drug – which is sold by Genentech – will remain on the market to treat cancers that […]
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Did FDA Make The Right Decision About Avastin?
Now that the FDA has formally withdrawn the breast cancer indication for Avastin, still more debate is likely to break out. As you may recall, the agency acted after a handful of trials demonstrated the med was not safe and effective for this use, reversing a decision that was made as part of the controversial […]
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